Description

Ornidazole Impurity 4 CAS NO 898230-56-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Ornidazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Ornidazole API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurities.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Ornidazole batches meet pharmacopeial (e.g., USP, EP, BP) and internal purity specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Essential for preparing impurity data packages required for drug master files (DMFs), ANDAs, and other regulatory filings with agencies like the FDA and EMA.
• Research & Development: Utilized in pharmaceutical R&D to understand the degradation pathways and chemistry of Ornidazole.

Basic Information

Product Name	Ornidazole Impurity 4
CAS No.	898230-56-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole; Ornidazole Related Compound; Ornidazole EP Impurity; Ornidazole USP Impurity; Ornidazole Degradation Product; 1-(3-Chloro-2-hydroxypropyl)-2-methyl-4-nitro-1H-imidazole; Ornidazole Impurity C (EP); Ornidazole Impurity D (USP)
EINECS	Contact for details

Quality Control

Every batch of Ornidazole Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference retention time
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.